Dosing and uses of Taltz (ixekizumab)
Adult dosage forms and strengths
solution for subcutaneous injection
- 80mg/mL
- Available as autoinjector or prefilled syringe
Psoriasis
Indicated for adults with moderate-to-severe plaque psoriasis
Week 0: 160 mg SC (ie, as two 80-mg injections), THEn
80 mg SC q2wks at weeks 2, 4, 6, 8, 10, and 12, THEn
80 mg SC q4wks
Dosing Considerations
Evaluate patients for tuberculosis (TB) prior to initiating treatment
Pediatric dosage forms and strengths
Safety and efficacy not established
Taltz (ixekizumab) adverse (side) effects
>10%
Injection site reactions (17%)
Upper respiratory tract infections (14%)
1-10%
Serious infections (3%)
Nausea (2%)
Tinea infections (2%)
<1%
Serious hypersensitivity reactions
Warnings
Contraindications
Previous serious hypersensitivity reaction (eg, anaphylaxis) to drug or excipients
Cautions
May increase the risk of infection; instruct patients to seek medical advice if signs or symptoms of infection occur; if a serious infection develops or an infection is not responding to standard therapy, monitor the patient closely and discontinue ixekizumab until the infection resolves
Evaluate patients for TB prior to initiating treatment; do not administer to patients with active TB; initiate treatment of latent TB prior to administering ixekizumab; consider anti-TB therapy prior to initiating in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed; monitor closely for signs and symptoms of active TB during and after ixekizumab treatment
Serious hypersensitivity reactions reported, including angioedema and urticaria; if a serious hypersensitivity reaction occurs, discontinue drug immediately and initiate appropriate therapy
Monitor for onset or exacerbation of Crohn disease and ulcerative colitis
Prior to initiating drug, consider completion of all age-appropriate immunizations; avoid use of live vaccines
Pregnancy
Pregnancy
There are no available data regarding use in pregnant women to inform any drug-associated risks
Human IgG is known to cross the placental barrier; therefore, ixekizumab may be transmitted from the mother to the developing fetus
Animal studies
- Unknown if distributed in human breast milk
- Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
Lactation
Unknown if distributed in human breast milk
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Taltz (ixekizumab)
Mechanism of action
Humanized monoclonal IgG4 antibody that targets interleukin-17A (IL-17A) and neutralizes the proinflammatory effects of IL-17A
IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses and plays a key role in the pathogenesis of plaque psoriasis
Absorption
Bioavailability: 60-81%; higher when administered in thigh vs arm or abdomen
Peak plasma time: 4 days
Peak plasma concentration: 16.2 mcg/mL
Trough plasma concentration (steady-state at ~10 wk): 9.3 mcg/mL
Distribution
Vd (steady-state): 7.11 L (increased with increased weight)
Metabolism
The metabolic pathway has not been characterized
Humanized IgG4 monoclonal antibodies are expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous Igg
Elimination
Half-life: 13 days
Systemic clearance: 0.39 L/day (increased with increased weight)
Administration
SC Preparation
Before injection, remove autoinjector or prefilled syringe from the refrigerator and allow to reach room temperature (30 minutes) without removing the needle cap
Inspect visually for particulate matter and discoloration prior to administration
Should appear as a clear and colorless to slightly yellow solution
Do not use if the liquid contains visible particles or is discolored or cloudy (other than clear and colorless to slightly yellow)
Does not contain preservatives; therefore, discard any unused product remaining in the autoinjector or prefilled syringe
SC Administration
Intended for use under the guidance and supervision of a physician
Patients may self-inject after training in SC injection technique using the autoinjector or prefilled syringe
Instruct patients using the autoinjector or prefilled syringe to inject the full amount (1 mL), which provides 80 mg, according to the directions provided in the Instructions for Use provided in the Medication Guide supplied with the drug
Administer each injection at a different anatomic location (eg, upper arms, thighs, or any quadrant of abdomen) than the previous injection, and not into areas where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis
Administration in the upper, outer arm may be performed by a caregiver or healthcare provider
Missed dose: Administer as soon as possible; thereafter, resume dosing at the regular scheduled time
Storage
Sterile and preservative-free solution
Protect from light until use
Refrigerate at 2-8°C (36-46°F)
Do not freeze
Do not use if drug has been frozen
Do not shake
Discard used syringe/autoinjector in a puncture-resistant container
Not made with natural rubber latex
